Posted to MedZilla on 1/20/2020

Phaidon International

US-, Quality Assurance Manager Opportunity - Belgium - Leading global pharma company 452431241374-MZ


Quality Assurance Manager Opportunity - Belgium - Leading Global Pharma Company

My client, a global pharmaceutical company, is looking for a freelance Quality Assurance Manager for a 12 month contract, starting in July 2015. This will be an office based role, located in Antwerp, Belgium.

 Main responsibilities: 

  • Design Control
    • Ensure design control compliance
    • Identify applicable quality and regulatory requirements
    • Review and approve all project deliverables (internal and from suppliers)
    • Participate to risk management and usability engineering processes in accordance with ISO 14971 and IEC 62366
    • Participate to design reviews, approves/disapproves move to next phase
  • Regulatory Support
    • Compile the Technical File, ensure CE mark approval
    • Support regulatory submissions worldwide
    • Ensure alignment with drug development and regulatory teams

  • Quality Assurance
    • Participate to supplier qualification and audits
    • Review and approve change control, deviations and CAPAs
    • Assess new or revised regulations and standards

Skills/Experience required:

  • Experience in Quality Assurance and Regulatory Affairs
  • Medical device experience
  • Medical device and drug-device combination regulations for the EU and US
  • Design control process and risk management experience
  • GMP experience (ISO 134858)


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